Wednesday, January 7, 2009

Charles Nemeroff, Unleashed

It looks like Dr. Charles Nemeroff has found a way to wriggle out of the already loose leash clapped around his neck by Emory University.

For those who have forgotten about Dr. Nemeroff’s recent trials and tribulations, here’s a brief recap. He was the principal investigator of a $3.95 million NIH grant to study several drugs by GlaxoSmithKline. But he was at the same time making hundreds of thousands of dollars doing promotional talks for the same company, orders of magnitude higher than the NIH maximum allowed. In order to skirt these regulations, Nemeroff simply lied to Emory officials. According to the New York Times, he signed a letter dated July 15, 2004, promising Emory that he would keep his earning from GlaxoSmithKline to less than $10,000 per year. But that same day, Nemeroff was at the Four Seasons Resort in Jackson Hole, Wyoming, where he was earning $3000 for a talk for GSK, part of $170,000 in income he earned from the company that year—17 times the figure that he had agreed to.

Emory removed him as department chair shortly thereafter, but inexplicably kept him on as full professor and allowed him to re-apply for more NIH grants within two years. Nemeroff’s public statement revealed an alarming lack of remorse: “I regret the failure of full disclosure on my part that has led me to the current situation. I believe that I was acting in good faith to comply with the rules as I understood them to be in effect at the time.” Translation: “I’m bummed out that this is happening to me. I didn’t do anything wrong.”

Meanwhile, Emory’s “punishment” still allows Nemeroff to take drug company money for promotional talks in the guise of ACCME accredited activities. According to Emory’s letter: “He will be limited to accepting payment for ACCME-accredited speaking engagements sponsored by academic institutions or professional societies.”

But Dr. Nemeroff has already found a way to escape from this restriction. In February, Dr. Nemeroff will co-chair this CME seriessupported by Bristol-Myers Squibb called “Measurement Based Care Strategies for Depression.”

It is “jointly sponsored” by the University of North Texas Health Science Center (UNTHSC) and an obscure outfit called “Letters & Sciences.” Letters & Sciences (L & S) is presumably a MECC but a Google search shows that they have no website. They are listed as being an “approved provider” of CE credit for nurses by both the New Jersey State Nurses Association (NJSNA) and the California Board of Registered Nursing.

It is clear that L & S is on a Bristol-Myers Squibb gravy train, making their money by producing promotional CME encouraging doctors to prescribe plenty of Abilify for bipolar disorder and depression. They teamed up with UNTHSC to produce this recent CME series as well, which presumably pushes the use of Abilify for kids.

By teaming up with this shadowy MECC, Nemeroff is complying with the letter of his punishment but is playing fast and loose with its spirit. In specifying that Nemeroff is limited to CME events “sponsored by academic institutions and professional societies,” Emory is asking that legitimate institutions create and control the content. But in this case, we see the usual CME shell game in which a private MECC is creating the content and is paying a nominal “co-sponsor” to provide CME credit.

If I were Senator Grassley, I’d be sending letters to L&S, UNTHSC, ACCME, Nemeroff, etc…, asking:

--How did L & S obtain the grant from BMS for this program?--What is L & S? Where are they? Who is on their staff? Which medical writers are creating the content? How much money are they making from BMS? What percentage of their total income comes from events supported by BMS?--What, exactly, is UNTHSC doing as “co-sponsor” of the event? Are they simply extracting a healthy fee from L & S, in return for a cursory review of their paperwork and disclosure forms? Or are they actually managing the event and producing content?

Leashes always chafe, especially when the wearer feels no guilt. Sometimes, however, loosening the leash is precisely the wrong thing to do.

28 comments:

Charlie really is one of the world's biggest narcissists. When he gave grand rounds at my school, he complained that we did it at 8 AM, noting that at Emory they do it at 9 AM and it works out very well for them. "There's a reason we didn't go into surgery," he said, apparently not having gotten enough beauty sleep.

I would go one step further and call Dr Nemeroff antisocial, as his behaviors and actions show no remorse or concern for patients, much less his peers and colleagues.

Sort of like the crap we have witnessed at Wall Street and Congress? '09 needs to be a watershed year in squashing any tolerance of these behaviors of "Profs gone Wild"! After all, don't we as physicians owe to our colleagues in training to not be preyed on by these bastards of greed?

Maybe nasty comments on my part, but I feel it needs to be put out here, because I'd rather be wrong in saying it now than not, versus be chastized later for not speaking out.

The mailing for this CME program actually came around last year (2008), soon after the initial Grassley letter to Emory in October, listing locations all over the country for this program. But again I ask are you all so innocent and naive to not understand that CME sponsored by a company is going to be complimentary to that companies product?? If you want to know the ultimate punch line for a CME program all you need to do is look at the "sponsored by" statement at the bottom of the announcement and you will know what way the content will lean. Here is a suggestion for what to do when you receive an announcement for a CME program sponsored by a company, instead of getting all outraged and indignant, just throw the announcement in the trash and then DO NOT attend the program and that way your delicate sensibilities will not be affronted. And whatever you do do not go into the back room, I hear there is gambling back there.......

There have been multiple mailings for these programs. The mailing that Danny posted for the gig in Los Angeles next month arrived in my mail just last week. The entire road show covering 5 cities can be found here.

Let's face it, folks: We live in a post-superego age. There is no shame. There is no guilt. There is almost nothing to prevent people like Nemeroff and his ilk in the public (and patient) "trust" from acting out their brazen narcissistic (and, at times) sociopathic fantasies in order to obtain gluttonous glory, financial and otherwise. Maybe a generational shift will occur and things will change for the better. I, for one, won't be holding my breath! In the meantime, we have Grassley. In this regard, did you see how Emory’s initial response to Grassley actually tried to spin Nemeroff’s activities as “CME-like” and therefore not subject to reporting requirements? Grassley fired back a response to Emory’s President which basically threatened prosecution. It was only then that Emory permanently stripped Nemeroff of his chair. You can see the letter exchanges on Grassley’s website.

There can be only one punishment severe enough to send a clear and unambiguous message to all the Nemeroffs of this world: Emory let him go, or Sen. Grassley grab Emory by the kahunas and throw them in the House of Pain. A very public civil lawsuit by the US government, with all the embarrassing elements that comes along the discovery process. Of course, no settlement until the humiliation is complete.

For the record; I chose to remain anonymous because I did work for a CME firm that was VERY dependent of Nemeroff for its revenues. CME is a small world and I still need to earn a living.

Dr Nemeroff is a disgrace to the medical community. His ethics are,,, well, it appears that he has no ethics. His focus is "Show me the money." Sad, very sad. Even worse, Emory tolerates and approves of his behavior.

Just curious: I may be naïve (no news there) but if the American public is educated about Nemeroff (as they have been via this blog and others like it, and mainstream papers, like WSJ, NY Times and LA Times and others), why would any drug company put him up as a front man for their drug? I mean, hasn’t this guy’s credibility been destroyed? Who would believe a word out of his mouth???

The previous Anon commenter wanted to know why a drug company would continue to use a discredited hack like Nemeroff, after everything has hit the fan. I can only share this one anecdotal observation: When the Nemeroff stuff broke in the news, I mentioned the hub-bub to my psychiatrist, wondering what his take is on the whole thing. His response was to vehemently defend Nemeroff as one of the leading researchers and experts in the field, and that the "truth" about this witch-hunt would come out soon. I believe that my doctor, whatever his other strengths and/or faults might be, is dazzled by the celebrity of Nemeroff and will continue to view him and his endorsements with a bright shining halo effect. Cognitive dissonance indeed.

In response to the Jan 9 2PM anon commentor, I can give you my take why your psych MD supports Nemeroff: I would hazard to guess the doc is older than 55, has taken pharm money himself, and probably has his skeletons in his own closet regarding at least somewhat unethical behaviors. If I am wrong on any or all these assumptions, then I am sorry to voice them in a public forum like this, but I'll throw it out to be wrong knowing in my heart I'm more likely right.

I also would guess this doc sees at least 80 or more patients a week for med checks mostly to supplant his practice. After all, isn't that the message Nemeroff is selling in the first place?

Think about it. Even if you truly believe in innocent before guilty as an adage and believe Nemeroff deserves his figurative "day in court", not only are the allegations troubling to read, but Nemeroff's own comments and actions since Grassley's investigations have gone public show what this man is about.

He is antisocial to me. There is no place for this type of behavior in a field of treating people.

Nemeroff is a wolf among sheep, both for the patients he allegedly cares for, and the peers, both colleagues and residents who mistakenly turn to him for guidance. I know who this man is, not directly, but I had wolves like him in my training program, and if you didn't take a stand against their predatory actions, you were either eaten figuratively, or just stood hopelessly against the wall. And people of conscience and ethics should never tolerate behaviors so brazenly practiced by these "leaders" being exposed now.

Why is Nemeroff regarded as such "star" in the field of Psychiatry? I know he has published a ton, but most of his publications are in "B" and "C" level journals in our field. What major discovery or advance has he contributed to the field? The cortisol/adrenal/pituitary stuff is a bridge to nowhere (with apologies to Sarah Palin). I cannot for the life of me find any major contribution published in an A-level scientific journal. And I am in academic medicine! Will somebody please educate me in this regard?

What are your ideas about what a leader in academic psychiatry ought to be doing with respect to relationships with pharmaecutial companies and in participating in CME, and who if anyone sets a praiseworthy example?

TF: 80 patients a week? Carlat and you, maybe, but no psychiatrist I know. Med students, perhaps, at the very beginning of the rotation, when they don't know the ropes. You guys are semi-retired, or something.

The other thing is that the street clinician is senior to Nemeroff, leads and drives clinical innovation. Nemeroff, on his best day, will do a good job of spreading what clinicians have told him is working these days. The academic paper shuffler is a mere formal verifier of what the clinician has been doing for years.

Dan, I hope you can see your way clear to post this. If not, I will endeavor to get it out on other channels. Free speech! Keep up the good work!

Dear Dr. Carlat and the Carlat Psychiatry blog commenting community,

I have read this web site on and off for some time related to my roles as a medical school faculty member involved in various departments including psychiatry, and an administrator with a regulatory compliance role. While the views expressed in the blog have tended toward the colorful, sometimes entertaining, often inappropriate, and occasionally libelous (dubiously protected by the disclaimer that the blog is only "opinion"), I think Dan has reached a point with this latest blog that has crossed an important line that responsible minds might want to pause and consider. I spent some time on this because of family history involving bullies like Dan, and mobs like most of the commenting community here, so I disclose my emotional COI in confronting this sort of behavior.

Spurious allegations are made in Dan's blog, on the basis of what looks like something under 5 minutes of "journalistic" investigation and a "tip" from the infamous Dr. Bernard Carroll, against one of the higher-quality CME providers, Letters & Sciences (L&S), whose primary work is in fact in oncology, not psychiatry. L&S, ironically (or tragically given the allegations, they'll never want to support any education in psychiatry again and probably don't need to), has a track record that the rest of the medical education companies (MECs) serving psychiatry might do well to emulate.

Dan's blog, not for the first time, veers into the land of blacklisting, aligning with the McCarthyistic tactics of Senator Grassley without portfolio or evidence to support the allegations. Of course, Dan has his own COI, where fanning the flames of the mob supports his brand name and his business. Someone will eventually sue Dan for these tactics, if it has not happened already, but his business model with the disclaimer about this only being "his opinion" rather than "journalism" would require actions to be filed in federal court and years before anything goes to trial, so I'm sure he banks on being able to bully folks and get not push-back before they're already in the grave due to the defamation. Sadly, history has seen many Dan Carlat's before, and the mobs that thrive on the blood, but it is very unfortunate when this plays out in the field of medicine where therapeutic opportunities or failures, and education to reduce risk, can affect patients' lives.

I have no financial stake in L&S, and have never posted anything anonymously in my life, but this blog's comments routinely state that anyone disagreeing with the prevailing view must be guilty of something, and acceptable tactics these days seem to include targeting anyone who would defend "the guilty". Therefore, please forgive my anonymity. From what I have gathered, with apparently more fact-checking than Dan engaged in (and it did not take more than 30 minutes), L&S has a track record of driving the laggard field of psychiatry toward the "brave new world" of multi-sponsor programs (an intrinsic protection against bias) that is already common in cardiovascular medicine, diabetes and oncology, while other MECs serving psychiatry are almost universally single-sponsored affairs. Standard business practices for L&S appear to exceed AACME standards based on my fact-checking, with required faculty attestations about the source of presentation content, high marks from faculty and audiences on judgments of "fair balance", blinded evaluations of applications to sponsors, third party review of all content, sponsorship in some cases where there is no discernable relation to any product the company has (presumably because companies see some long-term value of supporting programs with a company that has a loyal following due to high quality), and the use of non-profit venues like art institutes instead of Hiltons. I'm not surprised at the attack really, since I've been hearing that some "reformers" make no distinction between the highest and the lowest quality MECs, with the agenda of eliminating all for-profit MECs, but what's not made clear is that Dan is in competition with L&S. I dare say that the quality of L&S's CME offerings, and their apparent reputation of fair balance, seems to exceed the quality and fair balance of Dan's work, but that's my opinion.

It is more or less "par for the course" these days for Dan and most commenters to assume that individuals accused of something are guilty until proven innocent and perhaps this group would say that any "innocent" finding was somehow flawed. It also seems that many commenters feel they have special knowledge that all the "bad people" trashed herein have unsavory personality characteristics like "narcissism", because all those commenting have examined these people or have found a way to diagnose such things without a history and examination, and they're certain it's not a "projection". It is certainly popular these days to make spectacular allegations that one or a few "narcissistic" individuals are somehow responsible for the out-of-control, non-evidence-based behavior of so many individual psychiatrists. In fact of course, individual psychiatrists are personally responsible for their individual (often wild) use of non-evidence-based approaches, when there is increasingly a solid evidence basis for specific treatment algorithms. Call me crazy, but many practitioners seem to still need continuing education. Before we kill off L&S, perhaps we should take a look at the bigger issues with the behavior of the population of individual psychiatrists, and stop blaming drug companies, Joe Biederman and Charlie Nemeroff for what's wrong with the field. Grow up guys. Dan, you owe L&S an apology.

Re the above lengthy comment by Anonymous, I would like to say that responsible, attentive, and ethical people pay attention to deeds and not words first.

When you engage in behaviors/choices/paradigms that have an air of inpropriety up front, you better be prepared to be challenged, and that some will conclude, prematurely or not, you are guilty before innocent, especially if you keep upping the bar in questionable choices.

If you, anonymous, are going to argue that it is unfair to challenge the reliability and independence in studies/recommendations when they are subsidized by an organization that has a profit agenda, you sir, are not being transparent. And that is the point to this blog site to me. Yes, I use an alias, but my identity is clear to Dr Carlat, so there is some level of transparency by me. It is the other commenters that give me pause to speak completely transparently, mostly colleagues.

My profession has too large a share of vindictive, nasty, insensitive people. I know, because I have tangled with them during and since residency.

And why, because of money, prestige, and power.

Power corrupts, and absolute power corrupts absolutely. Please do not argue this point, or your validity in this debate is lost.

And, I sense an air of deflection and projection onto Dr Carlat by some of your comments. His transparency is lucid and direct to me, and he has apologized when wrong in the past. Read that anywhere from the usual suspects in the Grassley investigations? Oh, I forgot, honest and direct people always wait until all the court matters are exhausted until truth is completly established.

When you defend inpropriety, you are guilty by association as far as I am concerned.

You are right though, that individual practitioners are responsible for their choices and actions at the end of the day. Hence my comment about what you find at the bottom of cliffs, as we all know the adage about jumping off them like everyone else. What is wrong about challenging the message before everyone runs with it?

Didn't Lilly do a wonderful job in promoting Zyprexa? How many CMEs had their name on it from '96-06?

Now, how many psychiatrist reading this site consider it a first line agent as of now? It would be an interesting poll. Sort of what I would like to read about Seroquel in another year or two.

As I have said before, keep up your efforts Dr C; pharma's agenda has too many cohorts!

You're right in that I am, indeed, making allegations, but they are hardly "spurious". Emory has restricted Dr. Nemeroff to CME talks sponsored by academic institutions. This activity is co-sponsored, and apparently fully organized, by Letters & Sciences, which is not an academic institution, although they have adopted a name that conjures up the image of a university. L & S is a for-profit MECC, which would not exist without large lump sum payments from pharmaceutical companies, whether those companies make psychiatric drugs or oncological drugs. L & S is in the business of allowing pharmaceutical companies to advertise their products under the guise of accredited CME, which in my opinion is inherently a dishonest and corrupt business, no matter who does it, and no matter how "multiply sponsored" it is. I know that the good people who run L & S have read this posting, and I encourage them to respond to my questions regarding what, exactly, is their role in this particular series of CME programs. If their role is to organize and produce the series, then I believe that Dr. Nemeroff is skirting the rules Emory has instituted for him.

You appear to know a great deal about L & S's business practices, and I would be curious how. I have spent far more than 5 minutes trying to research who and what they are, and there is precious little on the web. If you have any links to document your claims of blinded review of applications, etc...., please provide them.

I appreciate getting my comments posted and the response from therapyfirst and Dan. Unfortunately, their only response is the predictable ad hominem attack, rather than substantive replies to the issues I raised. Goodnight for now gentlemen.

He says, "Spurious allegations are made in Dan's blog, on the basis of what looks like something under 5 minutes of "journalistic" investigation and a "tip" from the infamous Dr. Bernard Carroll, against one of the higher-quality CME providers, Letters & Sciences (L&S)…"

The allegations were not against Letters & Sciences – they were against the disreputable Charles Nemeroff for apparently violating the sanctions recently announced by Emory University and communicated to NIH. See http://www.pharmalot.com/wp-content/uploads/2008/12/emory-letter-to-nih.pdf

Here is the relevant sanction announced by Emory:

6. Speaking: a. Meetings and conferences. Dr. Nemeroff may accept invitations to lecture at other academic institutions and at the meetings and conferences officially hosted by scientific and clinical professional societies …

b. Other events. Dr. Nemeroff is prohibited from speaking for compensation at any other event unless it is an ACCME-accredited educational event hosted by an academic institution or a professional society.

Does “Anonymous” seriously want to claim that Letters & Sciences is an academic institution? Does “Anonymous” seriously want to say that road show events in Chicago, San Francisco, Los Angeles, New York, and Boston organized by Letters and Sciences qualify under 6a above? Does “Anonymous” seriously want to say that having a school of osteopathic medicine (University of North Texas Health Sciences Center) sign off on CME credits for the road show is consistent with the spirit of Emory’s sanction of Dr. Nemeroff?

If Letters and Sciences is affected negatively by this episode then any damage is self-inflicted. They should know better than to trot out a shopworn and compromised KOL like Charles Nemeroff. Their funding source, Bristol Myers Squibb/Otsuka should know better, too.

Hey, Dr. Anonymous, it's not necessary to put those annoying quote marks around "narcissist". I'm a board-certified psychiatrist, and I know 'em when I see 'em. I didn't share other anecdotes, like my residency interview with him, to support myself, but I easily could have. This one's a slam dunk.

Anonymous does seem rather vested in this MECC, having thrown the kitchen sink at DC, including the most devious of suggestions -- that "Someone will eventually sue Dan for these tactics [defamation], if it has not happened already."

If nothing else, we can all agree that the blogosphere -- as rough and tumble as it might get -- is a free speech forum due all First Amendment rights and that ANYONE, including an anonymous writer, should refrain from integrating knee-jerk legal threats into a debate about medical ethics.

That we should bring Dr. Nemeroff to task is a given. However let us keep things in prospective. I have attended at least 10 lectures of his over the years and have not detected any bias in the lectures. Sometimes I have not been able to even tell who was sponsoring the talk without looking at the handout. When I have presented difficult pts to him he has given great advice and not once recommended a drug from a company he received money from. Let us not forget the work he has done and continues to do with PTSD and child abuse. He has used openly sponsored drug lectures to talk about non drug related issues.

At least he isn't sitting in his office, hardly seeing pts anymore writing sensationalized newsletters just to make a living. What does publishing comments like C. N. is a Narcissist do to further a real discussion about these important issues? Talk about conflicts of interest. You have fallen to the level of The National Inquirer. What next? C. Nemeroff fathered Britney Spears baby???? Think about it. Not once has he ever denied it.

"Why is Nemeroff regarded as such "star" in the field of Psychiatry? I know he has published a ton, but most of his publications are in "B" and "C" level journals in our field. What major discovery or advance has he contributed to the field? The cortisol/adrenal/pituitary stuff is a bridge to nowhere (with apologies to Sarah Palin). I cannot for the life of me find any major contribution published in an A-level scientific journal. And I am in academic medicine! Will somebody please educate me in this regard?"

It's been a while, but I remember looking closely at what Nemeroff was working on because HPA axis dysregulation is a major aspect of some acute and chronic psychiatric disorders. The phenomenon is not understood, but also shows up in critical care medicine.

On another subject, I saw a comment somewhere about the different personalities of clinicians and researchers who accept drug company money, and those who don't. The neurogenetic basis of personality is now at least partially understood, thanks to the work of the Washington U St. Louis school, and now part of the basis of the DSM. And SURPRISE, the HPA axis is part of this picture!.

I have as much disdain for Nemeroff as anyone. And I would very much like to place the entire blame for his egregious behavior on him. However, for those of us who have been in direct and regular contact with him, all of this business comes as no surprise. Indeed, there were some at Emory who literally as soon as Nemeroff was announced as new chair began searching for a new position. There are numerous people at Emory who knew and looked the other way, denied, or cowered in fear; from top administrators to every day support staff. If we truly want to change how business is done, we must look inside ourselves as much as point fingers at Nemeroff. People like Nemeroff will always be around to take advantage if people like us don't step up and say "no".

I won't tar L&S without facts, but given their lack of public web presence, my experiences in the Med Ed field don't make me very confident that they are substantially different.

Out of graduate school, I spent several years working for a good-sized Med Ed company. Like L&S, they often had affiliations with universities for particular CME products (slide kits, etc). But guess who the owner of this Med Ed company was. It was the pharma advertising company that was just down the hall -- same bosses, and personnel who worked for both.

Anonymous suggests that L&S's use of several sponsors would make for unbiased CME products, but I doubt that, given the bias people working in those offices have for pharma products, and keeping pharma happy to keep the money flowing.

Charlie attempted to screw me once, and for no reason. I actually thought he liked me and had spoken positively about him on more than one occassion. When I learned what he did, I shuddered. Now many many years later, this. It's really kind of sad.

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About Dr. Carlat

I am a psychiatrist in Newburyport, Massachusetts and an Associate Clinical Professor of Psychiatry at Tufts Medical School (but note that the opinions expressed in this blog are not those of Tufts). I graduated from the psychiatric residency at Massachusetts General Hospital in 1995, and am the founder and publisher of three CME newsletters, including The Carlat Psychiatry Report. In March 2012, I left the publishing world to work on conflict of interest issues for The Pew Charitable Trusts, as director of the Pew Prescription Project. I returned to Newburyport and Carlat Publishing in September 2014.